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Chronology of Occult and Gross Coagulopathy in Burn Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Medstar Research Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01638481
First received: July 9, 2012
Last updated: June 20, 2013
Last verified: June 2013

July 9, 2012
June 20, 2013
July 2012
December 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01638481 on ClinicalTrials.gov Archive Site
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Chronology of Occult and Gross Coagulopathy in Burn Patients
Determining the Chronology of Occult and Gross Coagulopathy in Thermally Injured Patients: A Systems Biology Approach

The purpose of the study is to identify the inflammatory and coagulation pathways and mechanisms that are activated immediately following burn injury, and how they affect outcomes in terms of organ failure and death. This study also addresses the limitation of current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in severely injured patients both in a comprehensive and rapid manner.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Burn injury patients will be enrolled in the study upon arrival at Trauma Center.

Thermal Burns
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  • Group #1 - Burns affecting less than 10% BSA
  • Group #2 - Burns affecting 10%-30% TBSA
  • Group #3 - Burns affecting 31%-50% TBSA
  • Group #4 - Burns affecting 51%-70% TBSA
  • Group #5 - Burns affecting >70% TBSA
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
85
June 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients, male or female, > or = 18 years of age, who arrive at Burn/Trauma Center with anticipated admission to The Burn Center within 4 hours of injury, with a thermal burn injury due to flash, flame, contact with hot object or liquid.

Exclusion Criteria:

  • Patients suffering concomitant trauma that are in hemorrhagic shock. Patients with a preexisting history of coagulopathy, or currently taking anti-coagulants. Children and pregnant women. Patients with chemical or electrical injury. Patients who do not fluently speak either English or Spanish.
Both
18 Years and older
No
Contact: Michelle Mendoza, MD, CCRC 202-877-6181 michelle.mendoza@medstar.net
United States
 
NCT01638481
58802-LS
No
Medstar Research Institute
Medstar Research Institute
Department of Defense
Principal Investigator: Jeffrey Shupp, MD Washington Hospital Center
Medstar Research Institute
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP